Showing posts with label methylphenidate HCl. Show all posts
Showing posts with label methylphenidate HCl. Show all posts

Sunday, November 26, 2017

New 2017 Generics for Concerta

Deja vu. I feel like I've been through this before.

Two of my most-read blogs were about generic forms of Concerta available in 2013-14. The FDA had allowed companies to manufacture and sell tablets that were not the same as Concerta. People across the country noticed the change immediately. I started seeing patients who had been well controlled on Concerta for a long time who suddenly were not able to focus, were more angry, and had other focus and behavior problems. Initially I had no idea there was a new generic, but one mother sent me a picture of the new pill and I knew instantly it could not be the same.

Now I've heard there will be new generics from Trigen Laboratories, Mylan and Impax Laboratories that do not use the special delivery system of Concerta once again. I'm worried because it took many many months of people filing reports with the FDA through MedWatch before the FDA finally stopped allowing the substitution. I hope the newly approved versions work better than the previous editions, but am worried not only because they don't use OROS technology, but there are several new versions coming to market and each could be different.

I have heard that the previously available OROS generic (made in the same factory as the name brand Concerta and the same exact pill but with a different label) will no longer be available. If this is true, options will be to pay for the name brand or go with a new version of the medicine.

methylphenidate ER, Concerta, ADHD, stimulant, ritalin
These are all OROS type methylphenidate HCl ER (Concerta)


What makes Concerta unique?


Concerta is the branded formulation of methylphenidate HCl Extended Release that has a unique time release system. This time release technology is called OROS (osmotic controlled release oral delivery system). Unlike many slow releasing medications that are released as the capsule parts dissolve, the OROS capsule doesn't dissolve. There is a little active medicine that is released immediately and then the medicine is slowly released through a small hole in one end of the capsule. The pill works like a pump, pulling in water from the intestines, pushing the medicine out of the tube slowly throughout the day. This allows for a consistent drug release. See this photo from Medscape:

Source: https://www.medscape.org/viewarticle/547415_10

You can tell if you have the OROS tablets if they have a small dimple in one end:


The new generics


The same active ingredient (methylphenidate) is used in the new pills. I have heard that at least one version of the pills is round, so I know they don't use the OROS system. I cannot tell what type of delayed release they will have based on the information in their package inserts.

I find it very frustrating that each of the package inserts appear to be nearly identical to the one for Concerta (including the initial US approval date of 2000, which is not correct for this form). Older warnings, including a contraindication in those with tics, has been found in newer studies to not be a contraindication. The fact that they did not push to remove it makes me wonder if they did not want to have to change other parts of the document.

Figure 1 and Table 6 are identical with the exception of changing the word "CONCERTA" to "methylphenidate hydrochloride extended-release" and Trigen added an easy-to-read table format: 
Concerta
https://www.janssenmd.com/pdf/concerta/concerta_pi.pdf
Trigen's Methylphenidate HCl ER


Impax's Methylphenidate HCl ER


This makes me wonder if they were somehow able to get permission to make their new tablets based on Concerta's data, not their own. 

We'll see how it works in people who have previously taken OROS methylphenidate ER. Sadly, one version might work better than another, so you will have to keep track of which brand you are using.

What's good about the new generics?


If it's true that the currently available generic OROS form of methylphenidate ER is no longer going to be available, it's good that there will be other options to help keep costs down. Maybe. Sometimes insurance companies prefer branded products. It's all how they contract the cost. If you don't know how to use your insurance company's prescription formulary, you should learn. Also check out GoodRx for pricing information.

One might work as well (or better) than the OROS formulation in any individual. You won't know until you try it. 

One benefit I am excited about if these work: 
The Trigen version is available as a 72 mg tablet. The original Concerta is not able to be made at that strength. You can see from the photos above that the pills get bigger with increasing dosages, and the OROS system has limits to how much it can hold. For people who need 72 mg, they must take two of the 36 mg OROS tablets. Since patients pay by the pill and they need 60 pills/month instead of 30, this can be quite a bit more expensive.

What should you do if the pills change - especially if they don't work? 


Check each bottle when you pick up new medicine and ask if you can return unused tablets if they don't work for any reason. 

Keep track of what each pill looks like and the brand (which should be on the label) so you know which versions work and which don't. 

Talk to your kids about how they think and feel on and off their medicine - some will be more in tune with themselves than others.

Keep in touch with teachers as the pills change so you know if there are school-related issues you're not seeing at home.

If the pills don't work or have new or worsening side effects:
  • Talk to your HR representative who deals with the insurance company. 
  • Call your insurance company directly. Send them e-mails and snail mail. 
  • Ask your physician to write a letter on your behalf. 
In each of the above situations, include why your family member needs the OROS technology. Give examples of how it works better than the other extended release methylphenidates and why the amphetamine class of medication failed (if tried). 
If you need to change medications because the new generics don't work well, it helps to know what other medicines are in the same class so you can look up your formulary coverage. The ADHD Medication Guide has an easy-to-read format of ADHD medicines. Just look for other medicines in the same colored box as Concerta to find similar drugs. (To limit plagiarism of this wonderful chart, you must click on the user agreement in the center of the page. It is free and easy.) Medications have been arranged on the card for ease of display and comparison, but dosing equivalence cannot be assumed. Talk with your doctor about what medicines will be best for your child (or yourself). *The ADHD Medication Guide was created by Dr. Andrew Adesman of the North Shore-LIJ Health System.

Related Posts:

Tuesday, December 30, 2014

Concerta, Methylphenidate ER formulations, Shortages and Formularies

The popular ADHD medicine, Concerta, has been subject of a lot of debate in the past couple of years, and that is continuing into 2015.

This is from a Canadian blogger, but I love the picture showing the difference inside.


Problem #1: Generics vs Concerta

It started when companies started making generic formulations that had a different delivery system.  (If you haven't heard of the issue, you need to read this before reading further for it to make any sense.)

The FDA said that the non-OROS formulations are not acceptable substitutions in November 2014.

Even the same active ingredient in a different delivery system could cause a problem with a child who is doing well on one type of delivery system who gets a different type the following month. The drug releases into the body at a different rate, so the drug is distributed differently throughout the day. This can be insignificant for some people, but can cause significant issues in others. I have heard that some children's medicine wears off much earlier (before the end of the school day) and much faster (leading to emotional and behavioral problems) with different delivery systems.

It is important that whatever delivery system a child does well on continues to be used. They are not interchangeable. Talk with your pharmacist every time you fill the prescription to be sure it is the same manufacturer, or in the case of Concerta, one of the manufacturers that makes the name brand or authorized generic.

Problem #2: Shortages

Since pharmacists can no longer use two of the three brands of generics to fill Concerta prescriptions, there is now a nationwide shortage of Concerta and the one generic that uses the OROS technology. The shortages are expected to last through the second quarter of 2015.

Problem #3: Formularies

To top it off, many insurance companies dropped Concerta and the authorized generic from their 2015 formularies. This means that if you buy the OROS methylphenidate medicine, it is not covered at all by insurance. You must pay cash and it does not count toward your deductible. This makes it out of reach for many most families. I am happy to see that some companies are adding it back to their formularies already -- I suspect there have been a lot of complaints. If it is not on your formulary and it is the medicine that works best for your family member, start complaining.

You will most likely need to try another medicine - or several other medicines - to make a good argument. If a formulary medicine also works, simply use it instead. Save yourself the trouble of going through the hoops to get the OROS methylphenidate. It is only if there is not a well tolerated and effective other option that you should fight for the OROS methylphenidate.

How do you fight the fight? Talk to your HR representative who deals with the insurance company. Call your insurance company directly. Send them e-mails and snail mail. Ask your physician to write a letter on your behalf. State why your family member needs the OROS technology. Give examples of how it works better than the other extended release methylphenidates and why the amphetamine class of medication failed. People were able to get the FDA to look into the issue and they agreed that there are significant differences, so insurance companies cannot pretend that it is an equal substitution.

Finding the right medicine


Due to the formulary changes and the shortage of OROS methylphenidate, I have heard that pharmacists are telling patients that they cannot fill a prescription because it cannot say "Concerta" and that they doctor must re-write the prescription as "methylphenidate ER" for them to be able to fill it. This means that they will fill it with the non-authorized generic formulation. If your child has done well on a non-OROS medicine in the past, great! If not, you must find out if it is a formulary issue or if the pharmacy is out of stock of one of the brands, since the remedy is different for different issues.

You will need to check on your formulary, usually available on your insurance company website, for the amount in milligrams that is allowable. It might be that another generic formulation of methylphenidate, not one for Concerta, is on formulary. Concerta comes in very odd sizes (18mg, 27mg, 36 mg, 54mg) and most others come in multiples of 5s or 10s. So if your formulary has only methylphenidates in multiples of 5s or 10s, you know that your child will not be getting the OROS formulation. It is more tricky if the odd sizes are available on the formulary, because unless the prescription says "Concerta", the pharmacist can pick which one to use.  All the pills with the OROS technology say "ALZA" on the pill. Look at the pills before finalizing the purchase and keep your child's medicine the same from month to month unless there are problems on it.

If a prescription is written "methylphenidate ER __ mg" instead of "Concerta __ mg" a pharmacist can fill with any of the long acting methylphenidate medicines that are the same strength, regardless of it is is OROS technology or another form of long acting medicine. The problem is that the same strength of the same active ingredient does not become usable at the same rate due to the delivery system of the pill, so try to keep your child on the same brand if he does well on it. If he doesn't do well on it, it might be better to simply try a different brand with a different delivery system, if allowable by your insurance and available at the pharmacy.

Since the prescription can no longer say "Concerta" if you want to try the other formulation, it might take a few trips between the doctor's office and the pharmacy to find a prescription to match the medicine available at the pharmacy that is covered on your formulary. Each might require a prior authorization before being able to finalize the purchase, so anticipate a few days to weeks before you will be able to take home the medicine.

It will be difficult to deal with drug shortages once the formulary issue is resolved. If your insurance allows 90 day prescriptions, this might be a good option once the dose is optimized. (This is not a good option for the first few months of a new medicine because dose changes might be needed.) Be sure to fill a new prescription as soon as possible to give time for the pharmacy to order in the drug if needed and to have any required prior authorizations completed by your doctor.

Take a deep breath. Slowly exhale. This will all pass in time, but it will be a rocky road for a bit.

Tuesday, July 22, 2014

Learning and Behavior Series Part 5: Medications

This is the 5th post in a series of blogs on Learning and Behavior. It will focus on prescription treatments used primarily for ADHD.


There are many parts to the treatment of ADHD including behavior modifications; school accommodations; optimizing nutrition, sleep, and other healthy habits; and supplements -- all covered in previous posts in this series. This one will cover common medications that have been approved or are commonly used for the treatment of ADHD. I am not going to go into how to diagnose ADHD here, but it is of course of utmost importance to have the correct diagnosis before medication is considered.

There are many treatments out there that are not approved for the purpose being used, but if done properly might be a good consideration. Physicians sometimes use treatments that have not been approved for the purpose because they know from experience that it works or they are at a loss from approved treatments failing and they need to try something else.
One example is using a shorter acting form of guanfacine (Tenex) that has not been approved to treat ADHD, but is less expensive than the longer acting form (Intuniv) that is approved for ADHD.

Another common example is the use of albuterol, a medicine that helps breathing with conditions that cause wheezing. It is not approved for use under 2 years of age, but it is commonly used for younger children with difficulty breathing -- and it helps them breathe, which might keep them out of the hospital and off of supplemental oxygen.

I do not think that all non-approved medicines are good or bad. It is a very individual decision of what medicines to use. Discuss with your doctor if a treatment is approved or if they are using something that is not. Although this is relatively common among people who treat children because many drugs have not been tested in children and have been "grandfathered" into use through experiences that show benefit, be sure the provider is not picking something that has no basis or supporting evidence, especially if he or she profits from the treatment.

Be very wary of anyone who promises a cure - if one really existed everyone would use it.

Medications approved to treat ADHD


Medications to treat ADHD fall into the following categories:

  • Stimulants
  • Methylphenidates (Ritalin©, Focalin©, Concerta©, Daytrana©, Metadate©, Quillivant©

  • Amphetamines (Adderall©, Vyvanse©, dexedrine) 

  • Non-stimulants
  • Atomoxetine (Strattera©
  • Guanfacine (Intuniv©
  • Clonidine (Kapvay©
  • Others are used off-label (no FDA approval for the purpose of ADHD treatment): Tenex, Catapres patch, antidepressants, and antipsychotics

When a medication is needed to control symptoms of ADHD, the first line medications are the stimulants unless there are contraindications. Non-stimulant medications are not found to be as effective as stimulants in the majority of children, but they do have a place in the treatment plan for some children. They are sometimes used in addition to stimulants for optimal results. For information on how these medicines, see A Guide to ADHD Medications. It reviews how stimulants act on dopamine and norepinephrine and various time release patterns of different medicines.

Side Effects

Parents usually worry about medication side effects, which is a very legitimate concern. Overall the medicines listed above are very well tolerated. If a child has side effects to one stimulant, they can usually do well on a different class (methylphenidate vs amphetamine). I often hear concerns that parents don't want their kids changing their personalities or becoming "zombies". If the right medicine is used at the appropriate dose, this is usually not a problem. Finding that right medicine and right dose might take some trial and error, but work with your prescriber to get to the right one for your child.

The most commonly observed side effects of stimulants are:


  • Decreased appetite – Appetite is often low in the middle of the day and more normal by supper time. Good nutrition is a priority, so encourage kids to eat the healthy "main course" first and leave the dessert out of the lunchbox. Short acting meds improve mid day appetite since they wear off around lunch time. Kids are often very hungry in the evenings when medicines wear off, so encourage healthy foods at that time. I have also seen some kids who have a really hard time off medicine sitting down to eat actually gain weight better on medicine because they can finish the meal.
  • Insomnia – Trouble sleeping is common with ADHD, with or without medicines. If it is due to the stimulant medicine, trouble sleeping may be relieved by taking it earlier in the day.
  • Increased irritability -- Moodiness is especially common as the medication wears off in the afternoon or evening and in younger children. It makes sense if you consider that all day they are able to focus and think before acting and speaking, but then suddenly their brain can't focus and they act impulsively. Typically kids learn to adjust to the medicine wearing off as they mature. Sometimes just giving kids 30 minutes to themselves and offering a healthy snack can help. Cognitive behavioral therapy can help. 
  • Anxiety -- Anxiety does occur with ADHD and might be under-appreciated before the ADHD symptoms are treated. When kids can focus better, they might focus more on things that bother them, increasing anxiety. It is also possible that anxiety is misdiagnosed as ADHD, which is one reason for stimulant medication failure.
  • Mild stomach aches or headaches -- Stomach aches and headaches are occasionally noted with stimulant medications. It is my experience that they are most common with a new medication or a change in dose. Because these have many causes, it can be hard to determine if they are really from the medicine or another cause. If they persist with the medicine, it might be needed to change to another.
  • Tics - Tics are related to treated and untreated ADHD. People with ADHD are more likely to have tics than the general population. It was once thought that tics were caused by the stimulant medicines, but it is now thought that they happen independent of the medicine, and medicines might even help treat the tics.
  • Growth -- Weight gain can be difficult for some kids on stimulant medications due to the appetite suppression on the medicine. Studies have shown a decreased final adult height of about 1-2 cm (1/2 - 1 inch), which most agree is not significant compared to the benefits in self esteem, academics and behavior children gain on stimulants.

Rare side effects of stimulants include hallucinations and heartbeat irregularities


  • I have only seen two children who could not tolerate stimulants due to hallucinations, but it is very scary for the family when it happens. Unless there is a significant family history of them, I don't know a way to predict which child is at risk. These are a contraindication for continuing that medication, but another type of stimulant or medication can be considered. 
  • Cardiac (heart) problems are overall a rare complication of stimulants and often times are not a contraindication to continuing the stimulant medicine. There is a small increase in blood pressure and heart rate, both of which should be monitored regularly while on treatment and if the treatment is stopped. 

A cardiologist should be considered to further evaluate a patient prior to starting a stimulant if there is any of the following:

  • Shortness of breath with exercise not due to a known non-cardiac cause, such as asthma
  • Poor exercise tolerance compared to children of the same age and conditioning 
  • Excessively rapid heart rate, dizziness, or fainting with exercise 
  • Family history of sudden cardiac death or unexplained death (such as SIDS) 
  • Family or personal history of prolonged QT syndrome, heart arrythmias, cardiomyopathy, pulmonary hypertension, implantable defibrillator or pacemaker 

Common side effects for the non-stimulants include the following:

  • Atomoxetine can cause initial gastroesophageal complaints (abdominal pain, decreased appetite), especially if the dose is started too high or if it is increased too rapidly. It can also cause tiredness and fatigue when it is first started or if the dose is increased too quickly. It can increase the blood pressure and heart rate, both of which should be monitored regularly during treatment with atomoxetine. There is an increased incidence in suicidal thoughts, though uncommon, so children should be monitored for mood issues on this medication. A rare complication of atomoxetine is hepatitis (inflammation of the liver with yellow jaundice and abnormal liver function labs). The hepatitis resolves with stopping the atomoxetine. 
  • Guanfacine and clonidine both cause fatigue and tiredness, especially when first starting the medication or with increases in dose. Clonidine is often used at bedtime to help kids with ADHD sleep. Both of these medications can lower the blood pressure and heart rate, and these should be monitored closely while on guanfacine or clonidine.


Getting Started


The first step in treating ADHD is getting a proper diagnosis. This should be done with input from parents and teachers since symptoms should be present in at least two settings. ADHD symptoms overlap with many other conditions, and if the diagnosis is not correct, medications are more likely to cause side effects without benefit. Do not jump into medication until the symptoms have been fully evaluated and a proper diagnosis is made according to DSM criteria.

Stimulant medicines are considered first line treatment for ADHD in kids over 5 years of age. There are short acting and long acting formulations available for each type of stimulant. There are advantages and disadvantages to each. Short acting medications tend to last about 4 hours, so can be given at breakfast, lunch, and after school, allowing for hunger to return as each wears off to help kids maintain weight. They are often used later in the day after a long acting stimulant wears off for teens who need longer coverage. Long acting medicines tend to last between 6 and 12 hours, depending on the medicine and the person's metabolism. The benefit is that people don't need a mid-day dosing, which for school kids means avoiding a daily trip to the school nurse, which can be socially non-acceptable for older children. It is also easier to remember once/day medication versus multiple times/day dosing. The downside is that some children don't eat well mid-day with long acting medicines.

In general it is recommended to pick one of the stimulant medicines and start low and titrate to best effect without significant side effects. Feedback on how the child is able to focus and stay on task, and reports of other behavioral issues that were symptoms in the first place should be received from teachers and parents, as well as the child if he is able. There are many things to consider that affect focus and behavior that are not due to the medicine: sleep, hunger, pain, illness, etc. It takes at least a few days to identify if the medicine is working or not or if other issues are contributing to the focus and behaviors. The younger the child the longer I usually advise staying on a dose so a parent has a chance to hear from the teacher how things are going. I usually don't increase faster than once/week. I rely more on the student's report in middle and high school, since those students can be more insightful and they have so many teachers throughout the day that most teachers are not as helpful. Older students who are in tune with their problems and how they are responding to the medicine might be able to increase every few days, as long as there are no confounding factors that could influence symptoms, such as change in sleep pattern, big test or other stressor, or illness.



Which medicine to choose?


As you see above, there are two classes of stimulants, methylphenidates and amphetamines. While some children respond better to methylphenidates, others to amphetamines, some do equally well on either, and some cannot tolerate either. It is not possible to predict which children will do best on any type, but if there is a family history of someone responding well (or not) to a medicine, that should be taken into consideration of which to start first.


Another thing to consider is whether or not a child can swallow a pill. Some of the medicines must be swallowed whole. If you aren't sure if your child can swallow a pill, have them try swallowing a tic tack. Use a cup with a straw, since the throat is narrowed when you tilt your head back to drink from an open cup. Another option is to put it in a spoonful of yogurt or applesauce and have your child swallow without chewing. If your child cannot swallow a tic tac, you can choose a medicine that doesn't need to be swallowed. Some come in liquid or chewable formulations. Some capsules can be opened and sprinkled onto food, such as applesauce or yogurt. There is a patch (placed on the skin) available for the methylphenidate group.


I would love to say that cost shouldn't matter, that we pick the medicine based purely on medical benefit, but cost does matter. Before you go to the doctor to discuss starting medicine (this or any medicine for any condition) look at the formulary from your insurance company. All other things being equal, if one medicine is not covered at all (or is very expensive) and another is covered at a lower tier, it is recommended to try the least expensive option first. Of course, if the least expensive medicine fails, then a more expensive one might be the right choice. Also check to see if a medicine requires a prior authorization, which might require that other medicines are tried first.

The ADHD Medication Guide is a great resource to look for generics (marked with a "G"), which must be swallowed whole or can be opened or chewed (see the key on page 2). The age indications listed on page 2 are those that have FDA approval at the ages listed, but there are a lot of times that physicians use medicines outside the age range listed. Some do not even have an age indication listed. These ages are due to testing results, and can be limited because one age group might not have been tested for a specific medicine. Note that the 17 year and adult medicines are different. Is there really a difference between a 17 and an 18 year old? Not likely.


Finding the right dose



It is recommended to start with one of the two main classes of stimulants with a low dose, and slowly increase to find the best dose. If that stimulant doesn't work well or has side effects that are not tolerated, then change to the other class of stimulant. If that one does not work, you can try a different medicine from the class of stimulant that worked best. If the third medicine doesn't work, then a non-stimulant can be tried. I also recommend re-evaluating the original diagnosis at this point, since ADHD might not be the cause of the issues and finding the right cause can lead to a better treatment.

Titrating the medicine goes something like this:

  • If symptoms are well controlled and there are no significant side effects, the medicine should be continued at the current dose. 
  • If symptoms are not well controlled and there are no side effects that prohibit increasing, the dose should be increased as tolerated. 
  • If symptoms are not well controlled (i.e. room for improvement) but there are side effects that prohibit increasing the medicine, consider a longer period of watching on this dose versus changing to a new medicine.

Things to consider


Time Off: Once a good dose is found, parents often ask if medicines need to be taken every day. Drug holidays off stimulants were once universally recommended to help kids eat better and grow on days off school. Studies ultimately did not show a benefit to this, and some kids really can't take days off due to behavior issues, including safety issues while playing (or driving for older kids). It also seems that when kids are off medicine they do not have good self esteem due to repeated failures, so taking medicine regularly is important to them.

When kids can manage their behavior adequately, it is not wrong to take days off. Stimulants work when they work, but they don't build up in the body or require consistent use. (This is not true for the non-stimulants, which are often not safe to suddenly start and stop.) Some kids fail to gain weight adequately due to appetite suppression on stimulants, so parents will take drug holidays to allow better eating. Days off the medicine also seems help to slow down the need for repeated increases in dosing for people who are rapid metabolizers.

Talk to your child's doctor if you plan on not giving your child the medicine daily to be sure that is the right choice for your child.

Remembering the medicine: It is difficult to get into the habit of giving medicine to a child every day. I wrote an entire blog on remembering medicines. My favorite tip is to put the pills in a weekly pill sorter at the beginning of each week. This allows you to see if you're running low before you run out and allows you to see if it was given today or not. These medicines should not be kept where kids who are too young to understand the responsibility of taking the medicine have access.

Controlled substances: Controlled substances, such as stimulants, cannot be called in or faxed to a pharmacy. They cannot have refills, but a prescriber can write for either three 30 day prescriptions or one 90 day prescription when they feel a patient is stable on a dose. Stimulants are not controlled substances because of increased risks to the individuals it is prescribed for, but because they have a street value -- teens often buy them from other teens as study drugs. This can be very dangerous since it isn't supervised by a physician and the dose might not be safe for the purchaser. It is of course illegal to sell these medicines. The DEA does monitor these prescriptions more closely than others. If the prescription is over 90 days old, many pharmacists cannot fill it (this will vary by state), so do not attempt to hold prescriptions to use at a later time.

Acids and Stimulants: It has been recommended that you shouldn't take ascorbic acid or vitamin C (such as with a glass of orange juice) an hour before and after you take medication. The theory is that ADHD stimulants are strongly alkaline and cannot be absorbed into the bloodstream if these organic acids are present at the same time. High doses of vitamin C (1000 mg) in pill or juice form, can also accelerate the excretion of amphetamine in the urine and act like an "off" switch on the med. In reality  have never seen this to be an issue. If anyone has noticed a difference in onset of action or effectiveness of their medicine if they take it with ascorbic acid or vitamin C, please post your comment below.

When Mom and Dad disagree: It is not uncommon that one parent wants to start a medication for their child, but the other parent does not. It is important to agree on a plan, whatever the plan is. Have a time frame for each step of the plan before a scheduled re-evaluation. If the plan isn't working, then change directions. If kids know it is a disagreement, they might fear the medicine or think that needing it makes them inferior or bad. Do not talk about the diagnosis as if it's something the child can control - they can't. Don't make the child feel guilty for having this disorder. It isn't fair to the child and it only makes the situation worse.


Having the medicine when you need it-- 


Refills: There is nothing more frustrating for a parent and child than to realize that there's a big test tomorrow and you have no medicine left and you're out of refills. Be sure to know the procedure for refills at your doctor's office. By federal law we cannot give more than 3 month's worth of a stimulant medicine. They cannot be called in to a pharmacy. In my office we see patients at least every 3 months (more often when starting a medicine or if changes are needed). I advise that they schedule the next appointment as they leave the office so they don't forget to schedule. I make these appointments longer than standard "sick" appointments, so it is hard to sneak one in on the same day. 
Travel: It is very important to plan ahead prior to travel. If you forget your child's stimulant, no one can call out a prescription since it is a controlled substance. You must plan ahead so that if a refill will be needed during the trip you will either be able to fill a prescription you have on vacation or you will need to fill the prescription in advance. Most people can get a prescription 7 days prior to the 30 day supply running out, but not sooner, so you might need to fill a couple prescriptions a few days earlier in the month each to have enough on hand to make it through your vacation. It takes planning! If you are out of town and you realize you forgot your child's non-stimulant, call your doctor to see if they will call it out. Many of the non-stimulants are not safe to suddenly stop, so they are likely to call it out. Insurance is not likely to pay for these extra pills though if it was recently filled. 
Lost prescriptions: We are able to give up to three prescriptions at one time, but most pharmacists will not keep the prescriptions. This means that you must know where the prescriptions are and not lose them for 3 months. Lost prescriptions are handled differently by different prescribers, but all should take them seriously due to the controlled substance rules of the DEA. If a parent reports losing them frequently, that usually leads to consequences, so be sure you know how your doctor handles this situation. I will generally allow a parent to write a letter documenting the lost prescription and I document this in the medical record in a way that is easy to see at future visits. If this repeats, I will not be able to continue to prescribe a controlled substance for that family, which only makes the child suffer. 
Mail order: Some insurance companies will allow mail order 90 day prescriptions. Some not only allow, but require them on daily medicines. Others do not allow it. In general I advise against a 90 day prescription if the dose is not established or if there are any concerns that it might not be the perfect dose. If there is any concern that it might need to be changed, a 30 day prescription is a better option. If you will need to do a mail order, be sure you schedule your appointment to get the prescription early enough to account for the lost time mailing. 

Before your visit:

Before you meet with your physician to discuss a new ADHD diagnosis or a possible change in treatment plan, be sure to get the following information and have it available at the visit or the visit will not be as productive as you desire:

  • Insurance formulary
  • Standardized testing from teachers, parents, and other significant adults 
  • Verify if your child can swallow a tic tac or pill 
  • Any contributing family history (family member responses to medications, family history of heart issues, etc)

More Quest for Health blogs on ADHD:


References and resources:

ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents

ADHD Medication Guide

Parents Med Guide

Risk of serious cardiovascular problems with medications for attention-deficit hyperactivity disorder.



Tuesday, December 17, 2013

Update on generic Methylphenidate HCl ER (name brand = Concerta)

My previous post on Generic Concerta has been very popular, but it has so many updates that it has become difficult to read. I'd like to highlight the important points to make it easier for all.

What makes Concerta unique?

Concerta is the branded formulation of methylphenidate HCl Extended Release that has a unique time release system. This time release technology is called OROS (osmotic controlled release oral delivery system).  Unlike many slow releasing medications that are released as the capsule parts dissolve, the OROS capsule doesn't dissolve. The medicine is slowly released through a small hole in one end of the capsule. The pill works like a pump, pulling in water from the intestines, pushing the medicine out of the tube slowly throughout the day. This allows for a consistent drug release. See this photo from Medscape:


The companies that make the OROS pills include the original maker, now Janssen Pharmaceuticals, Inc., and Actavis (formerly Watson). They are marked with "alza" and the number signifying the strength. They have a distinctive marking on one end that is the exit port (as above).
photo source: goodrx.com











see the "exit port"



What generics are available?

There are now several generic extended release Methylphenidate HCl ER formulations approved by the FDA to substitute for Concerta. Generics must have the same active ingredient, but can vary with how it is made and the fillers.

One company, Actavis (formerly Watson), makes an OROS Methylphenidate HCl generic. It is the same OROS pill as the branded pill, but it is sold as an authorized generic. These look identical to the pictures above.

I'm sure more generics will be made, but the two companies that make a non-OROS generic are Mallinkrodt and Kremers Urban. It is easy to see that the pills of each of these are different from the OROS above.

For more information on authorized vs true generics, visit ADHD Rollercoaster's blog on the subject.


From Kremers Urban:

photos from http://www.kremersurban.com/products/Product_Details.aspx?ProdName=MetaT&ProdID=62175-311-37

How will my child react to different formulations?

This is a difficult question because everyone responds to medicines differently. For some people the formulations that are not OROS might work better. For some either might work well. For others they might respond best to the one with OROS. It is important to know which brand is taken so that if there are variances in how it works you can identify if it might be due to a change in the formulation.


What can I do if my child is not tolerating a new formulation?

There are several things to do if your child is not responding well to a new formulation.

  • Identify which brand and strength it is and write it down in a place you will remember so you won't buy it again. Keep a list of all medications and general reactions (both good and bad) in case of future issues. 
  • Tell the prescribing physician about the reaction and be sure to let them know the brand your child did well with and the one that has negative effects. Your physician might not know about the different generics available, so let them know it is not the OROS pill. Otherwise they might assume a higher strength will fix the issue, and your child might not need that higher strength, just a different time release. Ask your physician to write "OROS only" on the prescription. State laws vary about how they must do this. A nice summary is found on the Epilepsy.com. (We are not specifically taught these things in medical school or residency, so you might need to share state laws with your physician.)
  • Tell the pharmacy that the medication they substituted is not working and see if they can exchange for the brand your child was previously doing well on. You might need to go "up the chain" at a big name pharmacy, since the local pharmacists don't have much say in what is purchased for the company. (They likely won't be able to substitute, but after enough phone calls to the pharmacists who might complain to the administrators, and directly to the people responsible for choosing the company through which they order, they might reconsider the substitution.)
  • Tell the pharmacy you will take all your business elsewhere because you cannot buy their substitution. Local "mom and pop" pharmacies are more likely to order your preference than any chain pharmacy. You might pay more, but if you can afford it and your child's response is better, it might be worth it.
  • Call ahead before picking up prescriptions. Ask the pharmacy which type of methylphenidate HCl ER they have for the strength you need. (It may vary between 18mg, 27mg, 36mg, etc.) Let them know you will or will not be filling at their store based on what they stock. 
  • See if your insurance company participates with a mail order pharmacy. Be sure that they use the OROS pills BEFORE getting a 90 day supply. Mail orders are often less expensive options, so it might be helpful if you are unable to find a generic OROS pill and must buy the name brand. Keep in mind that shipping time will delay getting the medicine, so think ahead and schedule your ADHD visits to get new prescriptions about 2 weeks before you need the refill!
  • Tell your insurance company about the issue. They are contracting with pharmacies for certain formularies, and if they don't know that their clients don't like a particular brand, they will keep going for the cheapest contract. They still might because money talks, but keep pressuring them!
  • Tell your HR department if your insurance through the office requires you to use a certain formulary drug or particular pharmacy that purchases a brand your child does not thrive on. They can take this into consideration when renegotiating contracts. Again, this only works if a big enough number of people complain.
  • Ask your physician if he would be willing to write a letter to your insurance company on your behalf.
  • Report adverse events to MedWatch. This can help everyone if they hear enough complaints. You can read about the program then click on the consumer - friendly reporting form. From that link click on the "consumer/patient" button on the right. This is how the FDA learns of drug problems. Hopefully if enough people submit reports they will look into the issue. They have looked at data from each of the generic companies prior to approving the distribution of these pills and they found the data supportive that the medicines were equivalent. They need to hear post-marketing concerns from use in real people.
  • Share information. Many people are struggling with new formulations and they don't realize why. 
  • UPDATE May 1, 2014: I'm excited to see that the FDA has the generics this on their watch list. Gina Pera's "We Did It! Concerta Generics on FDA Watch List" gives a great summary of how the process works and what we can all do to continue the fight. 
  • UPDATE Nov. 16, 2014: Generics that are non-OROS will no longer be automatically substituted. They will still be available. See ADHD Roller Coaster's blog on the topic for details.

Saturday, April 27, 2013

Generic Concerta Not Working Like the Brand Used To?

Note: there is an update of this post here. It is much easier to follow, since the original post has so many updates.


I used to be a huge fan of generics. They save money, right? They are equivalent to the brand name, right?

That's what I've always been taught and what I teach taught.


I've been jaded by many problems and now disagree with the above.
Generics aren't always cheaper than the brand name.
Some generics are not equivalent to the name brand.


A recent discussion on a psychology/pharmaceutical listserv I follow brought up the issue of generic Methylphenidate HCl not working as well as the brand name Concerta. Several members had some great insight into why this is. The discussion peaked my interest in the issue and I started looking online for information earlier this week.

Ironically today I went to pick up a family member's medicine. We have filled at the same pharmacy previously for generic "Concerta" and have always gotten the equivalent generic. When I looked at the pills in the bottle today, I told the pharmacy tech they weren't OROS (see below). She looked confused. She had no clue what I was talking about.  (Lesson to all: if you have any questions, ask to talk to the pharmacist. Hopefully they will understand the pharmacology better than the tech.)

Generics for Concerta (Methlyphenidate HCl) might have the same active ingredient, but have a completely different time release system, resulting in varying drug peaks in the bloodstream. The original generic for Concerta (from Watson pharmaceuticals) uses a special technology to time-release the active drug. This time release technology is called OROS (osmotic controlled release oral delivery system). There are several other time release methods. The active ingredient may be imbedded in various substances from which the medicine must exit slowly or a gel cap is filled with beads that dissolve at different rates. With the technology used by Concerta, the capsule IS the time release. It doesn't dissolve. The medicine is slowly released through a small hole in one end of the capsule. The pill works like a pump, pulling in water from the intestines, pushing the medicine out of the tube slowly throughout the day. See this photo from Medscape.

    from http://www.medscape.org/viewarticle/547415_10
I have recently learned that not all generic formulations of Methylphenidate HCl are using this technology. This alters the time-release nature of the active medicine.  For some people this substitute might be just fine, or even preferable. But if it seems like your medicine isn't lasting long enough, has times that it works well followed by times it doesn't until the next peak, or any other problems -- check your pills!

You can tell the difference by closely looking at the capsules. The OROS capsules are a unique shape, a little more blunted than a standard capsule. If you look really closely at the ends, you will find that one has a "dimple" where there is a small hole covered by a thin layer matching the rest of the capsule. I just happen to have at least one of three dosages:



Photos of the Mallinckrodt brand are now listed under "Updates."

So if any medicine doesn't work like it used to, look closely at the pill itself to see if it is the same as previously. If you don't have any left, ask the pharmacy for the company / maker of the medicines you've filled over the past several months. Let your doctor know if you can't use a substitution so they can specify "Watson brand only."  If the new "brand" works better, be sure to ask for that manufacturer.

Better yet, call ahead and see who the manufacturer is of the generic for Concerta sold at your pharmacy. Watson Pharmaceuticals is the one that makes the OROS system. If they don't use that generic and you plan to shop elsewhere, be sure to let them know why!

Let me know your experiences with generics... See the Updates below if you want to report your experience to the FDA.

Update 4/29/13:


Reporting Adverse Events: A pharmacologist from the listserv I mentioned above suggests that if you have an issue with the duration of action of a different brand of Methylphenidate HCl you should report it to the FDA. This will allow them to review cases and possibly stop the substitution of these non-equivocal products. Click on this link for the MedWatch Report. Thank you SS!

Manufacturer Clarification: Watson Pharmaceuticals is authorized to market Concerta in the US for Ortho McNeill Janssen Pharmaceuticals, the original manufacturer.

Teva markets another type (not OROS) in Canada and Mallinckrodt markets another type (not OROS) in the US.

Update 5/27/13:


Photos of the Mallinckrodt pills (from www.mallinckrodt.com):



As a comparison, the pill shape of the OROS pills (Janssen Pharmaceuticals, McNeil, and Watson all look identical -- from www.goodrx.com):







Update 10/5/13:

I just learned another company is making a generic for Concerta. A patient suddenly found the medicine to be not effective. It looked entirely different, so suspected it was the wrong medication. The pharmacist confirmed that it is another generic for Methylphenidate HCl ER from Kremers Urban Pharmaceuticals. The parent sent me this picture of the 18mg pill and I found the 27mg on the Kremers website:
From http://www.kremersurban.com/products/Product_Details.aspx?ProdName=MetaT&ProdID=62175-311-37

If your pharmacist says he can't order a drug because of a shortage, you can check to see predictions of how long the shortage will last at ASHP.org. Be sure to look closely for the generic name and if it is an extended or immediate release form because it can be confusing.

Update 12/12/13:

Watson Pharmaceuticals will now be called Actavis, so ask for the OROS pill instead of a brand. I think I will do a whole new blog on this topic since there are so many updates since April. Watch for it!

This is a great resource on the difference in authorized vs true generics: An Update on Generic Concerta.

Update 5/1/14:

I'm excited to hear that the FDA has this issue on their watch list. Please read Gina Pera's We Did It! Concerta Generics on FDA Watch List.

Update 11/16/14:

Generics that are non-OROS will no longer be automatically substituted. They will still be available. See ADHD Roller Coaster's blog on the topic for details.

Resources:


The Pre-MMA 180-Day Exclusivity Punt? What Gives? A legal blog explaining how medicines lose their exclusivity and can become generically available, specifically the Concerta dispute.

How To Tell The Difference Between Concerta and Generic Concerta A Canadian ADHD blog provided the picture of how to recognize the difference. Generic formulations have been available in Canada years prior to in the US.

Special thanks to the members of the Child-Pharm listserv!